BD Biosciences, Systems & Reagents

Complete recall history across all FDA and CPSC categories — 9 total recalls

BD Biosciences, Systems & Reagents appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (9)

FDA medical device enforcement actions by BD Biosciences, Systems & Reagents

Date Product Reason Class
Jun 15, 2015 BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, B... Instruments installed between June 2007 and September 2011 do not contain lab... Class III
Mar 23, 2015 CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent One lot of BD CD123 PE (ASR) has been determined to contain a low amount of C... Class II
Mar 6, 2015 BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostic... The circuit breakers on some BD FACSCalibur instruments may have the incorrec... Class II
Dec 19, 2014 Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for ... Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antib... Class II
Dec 19, 2014 CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: ... One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected s... Class II
Jul 18, 2014 BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete ... The outer box label contains the incorrect distribution date: Box states 201... Class III
Jun 6, 2014 BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer ... Laser cooling fans and internal fan of the associated fluidics cart are not o... Class II
Apr 4, 2014 Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against h... Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actua... Class II
Jun 29, 2012 BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS... Incorrect version of the CD was included with BD FACS 7 Color Setup Beads. Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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